NCT03455699

Brief Summary

The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data from the patients enrolled in the VeClose study (NCT01807585).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

February 28, 2018

Last Update Submit

April 10, 2019

Conditions

Great Saphenous Vein (GSV) With Venous Reflux Disease

Keywords

GSV

Outcome Measures

Primary Outcomes (1)

  • Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).

    Complete closure is defined as Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5cm.

    5 years

Secondary Outcomes (7)

  • Venous Clinical Severity Score (VCSS)

    5 years

  • Aberdeen Varicose Vein Questionnaire (AVVQ)

    5 years

  • Quality of Life survey (EQ-5D)

    5 years

  • CEAP classification ("clinical, etiology, assessment and pathophysiology")

    5 years

  • Satisfaction with Treatment

    5 years

  • +2 more secondary outcomes

Study Arms (3)

Experimental: VenaSeal SCS

Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA at the time of enrollment into the VeClose study (NCT01807585).

Device: VenaSeal SCS

Active Comparator: RFA

Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Heat is applied to the target vein using radiofrequency energy to ablate the target vein. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA at the time of enrollment into the VeClose study (NCT01807585).

Device: ClosureFast Radiofrequency Ablation (RFA)

Experimental: Roll-in (VenaSeal SCS)

Prior to initiation of the randomized cohort at each site for the VeClose study (NCT01807585), a non-randomized cohort of 2 subjects per site (roll-in phase) were enrolled and treated with VenaSeal SCS with endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc.

Device: Roll-In (VenaSeal SCS)

Interventions

VenaSeal SCSDEVICE

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Also known as: VenaSeal Sapheon Closure System, VSCS
Experimental: VenaSeal SCS
ClosureFast Radiofrequency Ablation (RFA)DEVICE

Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.

Also known as: ClosureFast
Active Comparator: RFA
Roll-In (VenaSeal SCS)DEVICE

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Also known as: VenaSeal Sapheon Closure System, VSCS, Roll-in
Experimental: Roll-in (VenaSeal SCS)

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects currently enrolled in both arms of the VeClose Study (NCT01807585) will be assessed for eligibility to enroll in the VeClose Five Year Follow-up Extension Study. All subjects must meet the inclusion criteria and must not meet the exclusion criteria. Assessment of eligibility is based on data available to the investigator at the time of subject enrollment. The subject will be considered to be enrolled in the VeClose Five Year Follow-up Extension Study after the informed consent is signed/dated and all of the study eligibility criteria have been met.

You may qualify if:

  • Enrolled in the VeClose study.
  • Able and willing to complete the required 5 year study visit including Duplex ultrasound exam.
  • Able and willing to provide written informed consent prior to study specific data collection.

You may not qualify if:

  • \. Withdrew consent from the VeClose study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Morrison Vein Institute

Scottsdale, Arizona, 85255, United States

Location

GBK Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

Radiology Imaging Associates (RIA)

Greenwood Village, Colorado, 80111, United States

Location

Prairie Education & Research Cooperative

Springfield, Illinois, 62701, United States

Location

MD Laser Skin & Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Vein Institute of Buffalo

North Tonawanda, New York, 14120, United States

Location

Inovia Vein Speciality Center

Bend, Oregon, 97701, United States

Location

Sentara Vascular Specialists

Virginia Beach, Virginia, 23452, United States

Location

Lake Washington Vascular

Bellevue, Washington, 98004, United States

Location

Related Publications (3)

  • Morrison N, Gibson K, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.

    PMID: 28411697BACKGROUND

  • Kolluri R, Gibson K, Cher D, Madsen M, Weiss R, Morrison N. Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):407-15. doi: 10.1016/j.jvsv.2016.06.017. Epub 2016 Aug 8.

    PMID: 27638993BACKGROUND

  • Morrison N, Gibson K, Vasquez M, Weiss R, Jones A. Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):978-989. doi: 10.1016/j.jvsv.2019.12.080. Epub 2020 Mar 20.

    PMID: 32205125DERIVED

Study Officials

  • Nick Morrison, MD

    Morrison Vein Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 6, 2018

Study Start

July 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 12, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(9)